Diagnostic Testing Market Size, Share, Growth, Trends 2024 to 2033

Diagnostic Testing Market Size and Growth 2024 to 2033

The global diagnostic testing market size was valued at USD 213.27 billion in 2023 and is expected to hit around USD 423.85 billion by 2033, growing at a compound annual growth rate (CAGR) of 7.10% from 2024 to 2033.

Diagnostic testing refers to the investigation of biological materials or information for the purposes of identifying, confirming, or monitoring disease, conditions, or health status. These various tests may include blood tests, imaging studies, molecular assays, genetic screening, among others. Diagnostic testing allows health care providers to make appropriate decisions on diagnosis, treatment, and management of diseases by the early detection of conditions, the ability to monitor the progression of disease, and the assessment of the effectiveness of treatments. Diagnostic tests are of prime importance for effective health care delivery that would improve patient outcomes.

The diagnostic testing market is important in increasing efficiency and accuracy in healthcare. It represents a wide range of services and products that attempt to achieve this goal of improved patient outcomes through early diagnosis and correct identification of patients. This is driven by an increasing demand for rapid and accurate diagnostic tests, new molecular diagnostics, and diagnostics that incorporate AI and ML into their platforms. A surge in the adoption of POCTs and at-home diagnostic solutions continues to enhance access to essential healthcare services, thus offering early diagnosis and treatment options for a range of diseases.
According to Aspire Circle, the whole industry of medical diagnostics accounts for only 4-5% of all healthcare expenditure but influences the remaining 95% of the cost. Also, almost 70% of the medical decisions related to early diagnosis of a disease, prognosis of patients, and selection of treatment are based on laboratory diagnostic results.

The National Library of Medicine, citing a study on cervical cancer screening in sub-Saharan Africa, observes that it ranges between 2 and 20.2 percent in urban areas, while it stands at between 0.4 and 14 percent in rural areas. It is reported that barriers to screening, as identified in countries like Malawi, include cultural influences, religion, lack of knowledge about cervical cancer, low levels of awareness about prevention procedures, confusion between screening and diagnostic tests, fear of stigma, and embarrassment about the screening procedure.

Report Highlights

• North America region has accounted revenue share of 37% in 2023.
• Europe has held second postion in 2023 and accounted revenue share of 28%.
• By type, the molecule diagnostics segment has accounted revenue share of 51.18% in 2023.

Diagnostic Testing Market Growth Factors

• Technological Advancements in Diagnostic Tools: The rapid growth of the diagnostic testing market, including molecular diagnostics, next-generation sequencing, and point-of-care testing, is enabled only by innovation in diagnostic technologies. These improvements have led to an increase in the appropriateness, speed, and access of diagnostic tests for more timely and appropriate treatments. The increasing prevalence of chronic diseases, such as cancer, diabetes, and cardiovascular disorders, raises the need for sophisticated forms of diagnostic testing. Advancing diagnostics enables timely diagnosis, thereby improving overall patient outcomes and providing economic health benefits in all cases.
• Government Initiatives and Regulatory Support: The government's initiatives to improve public health, together with supportive regulatory frameworks that enable innovative diagnostic technologies, will play a very important role in driving the market forward. Policies that encourage early detection and personalized medicine will further enhance the adoption of diagnostic tests.
• Growing Demand for Personalized Medicine: In the era of personalized medicine, treatment is to be done according to the condition of the individual patient based on their respective genetic makeup; this is a trend in the market. Diagnostic tests are important in finding out specific biomarkers that will guide the selection of personalized therapies.
• Increased Investment in Healthcare Infrastructure: Increase in investment in healthcare infrastructure in developing regions offers increased access to advanced diagnostic services. Investment in the growth of the market can be attributed to diagnostic tests increasingly becoming available and their adoption.

Diagnostic Testing Market Trends

• Expansion of Point-of-Care Testing (POCT): The diagnostic testing market is witnessing significant growth in point-of-care testing, which allows for rapid, on-the-spot diagnostics in various settings, including clinics, hospitals, and even at home. The demand for POCT is driven by the need for immediate results, which is crucial in managing acute conditions and infectious diseases. The convenience and quick turnaround times of POCT are leading to its widespread adoption.
• Integration of Artificial Intelligence (AI) and Machine Learning (ML): The use of AI and ML in diagnostic testing is becoming increasingly prevalent. These technologies enhance the accuracy and efficiency of diagnostics by analyzing vast amounts of data to identify patterns and predict outcomes. AI-powered diagnostic tools are particularly valuable in fields such as radiology, pathology, and genomics, where they assist in early disease detection and personalized treatment planning.
• Rise of Personalized Medicine: There is a growing trend toward personalized medicine, where diagnostic tests are tailored to the genetic and molecular profile of individual patients. This approach enables more precise and effective treatments, particularly in oncology. The development of companion diagnostics, which are tests designed to identify patients likely to benefit from specific therapies, is a key driver of this trend.
• Growth of Telemedicine and Remote Diagnostics: The increasing adoption of telemedicine is driving the demand for remote diagnostic testing. Patients can now access diagnostic services from the comfort of their homes, which is especially important in rural or underserved areas. Remote diagnostics, combined with telemedicine platforms, provide continuous monitoring and timely interventions, improving patient outcomes.
• Emphasis on Preventive Diagnostics: There is a growing emphasis on preventive diagnostics, aimed at detecting diseases at an early stage before they become more serious. Preventive diagnostics include routine screenings and genetic testing, which can identify risk factors and predispositions to certain conditions. This trend is fueled by the increasing awareness of the importance of early detection in improving health outcomes and reducing healthcare costs.

Report Scope

Diagnostic Testing Market Dynamics

Drivers

Increased Funding and Investment

• Significant investment from both public and private sectors in healthcare infrastructure and diagnostic technologies is driving market growth. This includes funding for research and development of new diagnostic tools and expanding diagnostic services in underserved areas.

Advancements in Telemedicine

• The integration of diagnostic testing with telemedicine platforms is providing patients with remote access to essential diagnostic services. This trend is especially important in rural and underserved areas, where access to healthcare is limited.

Restraints

Economic Volatility

• Economic instability and fluctuations in healthcare funding can restrain the growth of the diagnostic testing market. Budget cuts and reduced healthcare spending may impact the availability and affordability of diagnostic tests, particularly in low-income regions.

Regulatory Challenges

• Navigating complex regulatory environments can be a significant challenge for companies in the diagnostic testing market. Strict regulations and lengthy approval processes can delay the introduction of new diagnostic tests, affecting market growth.

Opportunities

Emerging Markets

• The diagnostic testing sector has significant growth potential in emerging markets, where there is a rising demand for advanced healthcare services. Expanding diagnostic services in these regions presents a substantial opportunity for market players.

Integration of AI and Machine Learning

• The incorporation of AI and machine learning into diagnostic testing is a promising opportunity for the market. These technologies can enhance the accuracy and efficiency of diagnostic tests, leading to better patient outcomes.

Challenges

Supply Chain Disruptions

• The diagnostic testing industry faces challenges related to supply chain disruptions, particularly in the availability of essential components and reagents. Ensuring a stable supply chain is critical for maintaining the quality and availability of diagnostic tests.

Skilled Labor Shortages

• A shortage of skilled healthcare professionals, including laboratory technicians and diagnosticians, can hinder the growth of the market. Addressing this challenge requires investment in education and training programs to build a skilled workforce.

Diagnostic Testing Market Segmental Analysis

Type Analysis

Molecular Diagnostics: This segment involves tests that detect specific sequences in DNA or RNA that may or may not be associated with disease. Molecular diagnostics is crucial in areas such as infectious disease detection, oncology, and genetic testing. With advancements in PCR and next-generation sequencing, molecular diagnostics continues to grow rapidly, offering precise and early detection of diseases.

Immunoassays: Immunoassays are diagnostic tests that rely on the reaction between an antigen and an antibody to detect diseases. Commonly used for hormone, infectious disease, and cancer marker testing, this type of diagnostic test is highly valued for its accuracy and specificity. The market for immunoassays is driven by their broad application and ongoing innovations that improve sensitivity and reduce processing times.

Clinical Chemistry: This segment covers tests that analyze bodily fluids (like blood or urine) to detect the presence of specific substances. Clinical chemistry tests are vital in routine health checks and chronic disease management, such as monitoring glucose levels in diabetes patients or cholesterol levels in cardiovascular disease management. The market for these tests is supported by the growing prevalence of chronic diseases and the need for regular monitoring.

Hematology Testing: Hematology testing involves the analysis of blood components and is essential for diagnosing conditions such as anemia, leukemia, and clotting disorders. As technology advances, automated hematology analyzers are becoming more sophisticated, allowing for more detailed and accurate analysis. This segment is seeing growth due to the rising incidence of blood disorders and the demand for comprehensive blood tests.

Microbiology Testing: This segment focuses on detecting and identifying pathogens responsible for diseases like bacterial, viral, and fungal infections. Microbiology testing is crucial in hospitals for infection control and is increasingly important due to the rise of antibiotic-resistant strains. Innovations in this area include rapid culture methods and the use of molecular techniques for faster and more accurate diagnosis.

Application Analysis

Oncology Testing: Cancer diagnostics, including screening and monitoring, represent a significant application of diagnostic testing. Tests for biomarkers, genetic mutations, and tumor-specific antigens are key in early cancer detection, monitoring treatment efficacy, and guiding therapy decisions. The growing emphasis on personalized medicine is propelling advancements in oncology diagnostics.

Cardiovascular Disease Testing: Diagnostic tests in this segment focus on detecting heart-related conditions such as coronary artery disease, heart failure, and arrhythmias. Tests include lipid panels, troponin levels, and ECGs, which help in assessing the risk, diagnosing, and monitoring the treatment of cardiovascular diseases. The high prevalence of heart diseases globally fuels the demand for advanced diagnostic tools in this area.

Prenatal and Newborn Testing: This segment includes tests performed during pregnancy and after birth to detect genetic disorders, congenital anomalies, and other health conditions in the fetus and newborns. Non-invasive prenatal testing (NIPT) and newborn screening are growing in popularity due to their ability to provide early and accurate detection, thereby improving health outcomes.

Metabolic Disorder Testing: Diagnostic tests for metabolic disorders, such as diabetes and thyroid conditions, are crucial for early detection and management. These tests often involve blood glucose monitoring, lipid profiling, and thyroid function tests. The rise in lifestyle-related diseases and the need for regular monitoring drive this segment's growth.

End-Users Analysis

Hospitals and Clinics: The primary users of diagnostic testing services, employing a wide range of tests for disease detection, treatment monitoring, and health assessments. The growing demand for accurate and timely diagnostics drives this segment.

Diagnostic Laboratories: These facilities process large volumes of diagnostic tests, providing services to hospitals, clinics, and other healthcare providers. The segment is expanding due to the increasing need for specialized testing and advanced diagnostic capabilities.

Research and Academic Institutes: Utilize diagnostic testing in research settings, focusing on understanding disease mechanisms, developing new treatments, and identifying biomarkers. This segment is crucial for the advancement of medical science and personalized medicine.

Biopharmaceutical and Biotechnology Companies: Use diagnostic testing in drug development, especially for identifying therapeutic targets and monitoring clinical trial outcomes. The segment is growing as these companies invest in developing new diagnostics and companion therapies.

Diagnostic Testing Market Regional Analysis

The diagnostic testing market is segmented into various regions, including North America, Europe, Asia-Pacific, and LAMEA. Here is a brief overview of each region:

Why is North America leading the diagnostic testing market?

The North America diagnostic testing market size was estimated at USD 78.91 billion in 2023 and is expected to reach around USD 156.82 billion by 2033. North America is leading the market due to its robust healthcare infrastructure and high demand for advanced diagnostic technologies. The U.S. and Canada are at the forefront of adopting cutting-edge diagnostic methods, including molecular diagnostics and next-generation sequencing. Significant investments in healthcare innovation, supportive regulatory frameworks, and a strong focus on early disease detection drive market growth. Additionally, the region’s emphasis on personalized medicine and precision diagnostics fosters the development of advanced diagnostic solutions.

Why Asia-Pacific experiencing rapid growth in the diagnostic testing market?

The Asia-Pacific diagnostic testing market size was accounted for USD 49.05 billion in 2023 and is expected to hit around USD 97.49 billion by 2033. The Asia-Pacific region is expanding rapidly, fueled by increasing urbanization, rising disposable incomes, and expanding healthcare access. Countries such as China, Japan, and India are seeing significant advancements in healthcare infrastructure and the adoption of innovative diagnostic technologies. The growing prevalence of chronic diseases, government initiatives to improve healthcare accessibility, and investments in healthcare technology are driving the demand for diagnostic testing. The region’s focus on developing affordable diagnostic solutions to cater to its large population further boosts market expansion.

Europe Market Trends

The Europe diagnostic testing market size was exhibited at USD 59.72 billion in 2023 and is anticipated to surpass around USD 118.68 billion by 2033. Europe's diagnostic testing industry is driven by its well-established healthcare systems and increasing demand for early and accurate disease detection. The region experiences growth due to supportive government regulations, expanded healthcare funding, and rising public awareness of preventive healthcare measures. Countries like Germany, the UK, and France are leaders in adopting new diagnostic technologies, including digital pathology and advanced imaging techniques. The focus on reducing healthcare costs through early diagnosis and the integration of innovative diagnostic tools into existing healthcare frameworks supports overall market growth.

LAMEA Diagnostic Testing Market is Expanding

LAMEA is expanding due to growing healthcare awareness and improving healthcare infrastructure. In Latin America, there is an increasing focus on modernizing healthcare systems and enhancing access to diagnostic services. The Middle East benefits from substantial investments in healthcare infrastructure and the adoption of advanced diagnostic technologies. Although Africa faces challenges such as limited resources and access to healthcare, progress is being made through international partnerships and funding initiatives aimed at improving diagnostic capabilities and access to essential healthcare services across diverse regions.

Diagnostic Testing Market Top Companies

• Roche Diagnostics
• Abbott Laboratories
• Thermo Fisher Scientific Inc.
• Siemens Healthineers
• Danaher Corporation
• Becton, Dickinson and Company (BD)
• Quest Diagnostics
• Bio-Rad Laboratories
• Hologic, Inc.
• Cepheid (a Danaher company)
• PerkinElmer, Inc.
• Agilent Technologies
• Qiagen N.V.
• Sysmex Corporation
• Ortho Clinical Diagnostics

Among the new players in the diagnostic testing market, companies like Guardant Health leverage advanced liquid biopsy technology to offer innovative solutions for cancer detection, enhancing early diagnosis and personalized treatment. Foundation Medicine focuses on developing comprehensive genomic profiling services, combining cutting-edge sequencing technologies with data-driven insights to support precision medicine.

Dominant players like Roche Diagnostics drive growth through their extensive product lines and recent introductions, including high-sensitivity tests for infectious diseases. Abbott Laboratories integrates advanced digital health technologies with its wide range of diagnostic tools, facilitating comprehensive solutions for various healthcare applications. Innovations and collaborations, such as Roche's new test launches and Abbott's strategic partnerships, underscore their leadership in the evolving Diagnostic Testing Market.

CEO Statements

Robert Ford, CEO of Abbott:

• "We have testing going on in airports, at retail stores, at doctor’s offices and then a whole app ecosystem so we now have a base so that when we can bring other tests (like) sexually transmitted tests, flu and RSV and strep tests, etc. Those will now go into that installed base that we’ve done and hopefully, now you will have a whole new channel of diagnostic testing."

Anand K, CEO of SRL Diagnostics:

• "Laboratories are now going closer to the patient than ever before. With extensive network presence, home services, comfort of digital platforms for test booking, payments, and report storage, labs are now offering 100% convenience to customers. Labs that do not adopt digital technologies and digital modes of delivery will lose out on this opportunity."

Han-Oh Park, Founder & CEO of Bioneer:

• "BIONEER is fully prepared for large-scale production of the Iron-qPCR system, with the Global Center that opened up last month. We see this as a great opportunity to move forward with deals at the country level in LMICs. BIONEER will target the global molecular diagnostics market with Iron-qPCR at the forefront."

Recent Developments

Key players in the diagnostic testing market are influential in providing a range of innovative healthcare solutions, including advanced diagnostic technologies, precision medicine tools, and digital health platforms. Some notable examples of key developments in the Diagnostic Testing Market include strategic acquisitions, partnerships to enhance diagnostic capabilities, and the introduction of high-sensitivity tests for early disease detection:

• In July 2024, Thyrocare Technologies Ltd. announced the acquisition of the diagnostic and pathology business of Polo Labs. This strategic acquisition enhances Thyrocare's service offerings and expands its presence in the diagnostic testing market, highlighting the company's commitment to growth and innovation in the healthcare sector.
• In June 2024, a student from Edinburgh University launched a new 15-minute HPV diagnostic device, designed to provide rapid and accurate results. This innovation represents a significant advancement in the field of diagnostic testing, offering a faster, more accessible solution for detecting HPV and potentially improving early detection rates.
• In May 2024, Molbio Diagnostics plans to deploy cutting-edge technologies to launch innovative diagnostic products, highlighting the company's commitment to advancing healthcare solutions and addressing critical needs in the diagnostics market.
• In March 2024, Siemens Healthineers announced its decision to close its Fast Track Diagnostics unit due to a significant decline in demand for PCR testing products post-pandemic. This decision reflects the shifting market dynamics and Siemens' strategic focus on optimizing its Diagnostics business. The closure, affecting approximately 90 employees primarily based in Luxembourg, is expected by September 2024.

These companies are expanding the market through acquisitions and innovation, aiming to advance accuracy, enhance accessibility, and introduce next-generation diagnostic tools. This includes high-sensitivity tests and AI-driven platforms, fostering collaboration between industry leaders and healthcare providers to improve patient outcomes.

Market Segmentation

By Type

• Molecular Diagnostics
• In Vitro Diagnostics (IVD)
• Point-of-Care (POC) Diagnostics
• Immunoassays
• Clinical Chemistry
• Hematology Testing
• Microbiology Testing

By Application

• Infectious Disease Testing
• Oncology Testing
• Cardiovascular Disease Testing
• Prenatal and Newborn Testing
• Metabolic Disorder Testing

By End-Users

• Hospitals and Clinics
• Diagnostic Laboratories
• Research and Academic Institutes
• Biopharmaceutical and Biotechnology Companies

By Regions

• North America
• Europe
• APAC
• LAMEA